塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.412785284278557527871252788394278503327862820.06
29.332791988279122827916080.02
单位质量响应值RSD%判断
296097.98299207.720.74数据可信
长期36月-供试品溶液-20211227批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11190549-119054939.83936.999.7339.8436.999.73
21263515-126351542.28142.28
31030018-103001834.46734.47
41095439-109543936.65636.66
51087230-108723036.38236.38
6966029-96602932.32632.33
10min11886609-188660963.13166.446.2263.1966.496.21
21944477-194447765.06765.13
32085867-208586769.79969.85
41816700-181670060.79260.85
52042582-204258268.35068.40
62136478-213647871.49271.54
15min12222677-222267774.37778.756.7974.5378.906.78
22310663-231066377.32177.48
32483860-248386083.11783.27
42126529-212652971.15971.31
52444783-244478381.80981.97
62531742-253174284.71984.87
20min12604125-260412587.14190.404.0887.4190.674.07
22673427-267342789.46089.74
32792425-279242593.44293.72
42546673-254667385.21985.47
52790254-279025493.36993.65
62801962-280196293.76194.04
30min13048625-3048625102.01599.303.11102.4199.703.08
23028084-3028084101.328101.74
32888383-288838396.65397.07
43072249-3072249102.806103.19
52902226-290222697.11697.54
62864655-286465595.85996.28
45min13067567-3067567102.64999.903.08103.20100.463.05
23034831-3034831101.554102.12
32923410-292341097.82598.39
43094945-3094945103.565104.10
52917794-291779497.63798.20
62873612-287361296.15996.73
60min13058268-3058268102.33899.643.14103.04100.343.12
23036669-3036669101.615102.33
32889714-288971496.69897.41
43088287-3088287103.342104.03
52911136-291113697.41598.13
62881173-288117396.41297.12
极限13051935-3051935102.12699.562.99102.98100.422.97
23029382-3029382101.371102.24
32896788-289678896.93497.79
43081157-3081157103.104103.95
52915784-291578497.57098.43
62876261-287626196.24797.10
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.412791883279132527882902786680278676627889890.09
29.332792282279228127922820.01
单位质量响应值RSD%判断
296385.65299279.960.69数据可信
长期36月-供试品溶液-20211228批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1648382-64838221.68336.5425.3621.6836.5425.36
21049895-104989535.11135.11
31394553-139455346.63746.64
41352990-135299045.24745.25
5948388-94838831.71631.72
61161159-116115938.83238.83
10min11561854-156185452.23261.4310.7952.2661.4910.81
21806038-180603860.39860.45
31970131-197013165.88665.96
42119094-211909470.86870.94
51691777-169177756.57756.62
61872939-187293962.63662.69
15min11887819-188781963.13380.7812.1763.2480.9312.18
22279665-227966576.23776.38
32665097-266509789.12789.30
42647293-264729388.53288.71
52471822-247182282.66482.80
62541860-254186085.00685.16
20min12253943-225394375.37790.739.1275.5891.009.13
22612870-261287087.38187.64
32904897-290489797.14797.45
42880420-288042096.32896.64
52800437-280043793.65393.91
62824928-282492894.47294.75
30min12861010-286101095.67998.702.0196.0099.112.04
22901805-290180597.04397.43
32958184-295818498.92999.38
43019393-3019393100.976101.43
52979427-297942799.639100.04
62988608-298860899.946100.37
45min12875982-287598296.18098.411.5696.6498.961.60
22904970-290497097.14997.68
32946352-294635298.53399.13
43002065-3002065100.396101.00
52954499-295449998.80599.35
62972713-297271399.41599.99
60min12891193-289119396.68899.151.7397.2999.841.77
22921503-292150397.70298.38
32957638-295763898.91099.65
43026594-3026594101.216101.97
52990292-2990292100.002100.70
63000773-3000773100.353101.07
极限12869989-286998995.97998.301.7596.7399.151.78
22895556-289555696.83497.66
32927421-292742197.90098.79
43005863-3005863100.523101.43
52962109-296210999.06099.90
62975131-297513199.495100.37
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.412792758279623427957902796265279525227952600.06
29.332792548279588027942140.09
单位质量响应值RSD%判断
297052.07299487.030.58数据可信
长期36月-供试品溶液-20211229批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11185522-118552239.58840.5016.1839.5940.5016.19
2976811-97681132.61932.62
31052078-105207835.13235.13
41269092-126909242.37942.38
51537077-153707751.32851.33
61256915-125691541.97241.97
10min11854052-185405261.91366.389.8561.9766.449.85
21886361-188636162.99263.04
31877516-187751662.69662.75
41890165-189016563.11963.18
52061266-206126668.83268.91
62357044-235704478.70978.77
15min12220156-222015674.13878.218.2374.2978.378.23
22250186-225018675.14175.28
32228885-222888574.43074.58
42292092-229209276.54076.70
52336080-233608078.00978.19
62725312-272531291.00791.19
20min12621556-262155687.54288.294.1087.8188.574.11
22546661-254666185.04185.30
32599429-259942986.80387.06
42646412-264641288.37288.65
52595630-259563086.67686.97
62854697-285469795.32795.64
30min12827130-282713094.40795.532.1294.8095.942.13
22789316-278931693.14493.53
32804366-280436693.64794.04
42924733-292473397.66698.07
52916740-291674097.39997.83
62901515-290151596.89197.35
45min12833938-283393894.63496.161.6795.1796.711.68
22843432-284343294.95195.47
32835791-283579194.69695.23
42941988-294198898.24298.79
52922800-292280097.60298.17
62899181-289918196.81397.42
60min12802176-280217693.57495.721.8594.2596.421.85
22832010-283201094.57095.24
32831920-283192094.56795.24
42933828-293382897.97098.67
52918351-291835197.45398.17
62880407-288040796.18696.94
极限12831411-283141194.55095.671.9495.3796.511.95
22802773-280277393.59394.40
32816671-281667194.05894.87
42935512-293551298.02698.87
52914435-291443597.32298.19
62889286-288928696.48297.38
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.412802481279978628060292802846280286428028010.08
29.332793908279605027949790.06
单位质量响应值RSD%判断
297853.45299569.020.41数据可信
长期36月-供试品溶液-DR8010批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1691814-69181423.06824.0939.2323.0724.0939.22
2731367-73136724.38624.39
3765535-76553525.52625.53
4267408-2674088.9168.92
51160170-116017038.68438.68
6718383-71838323.95323.95
10min12407694-240769480.28173.148.0680.3273.188.04
22299370-229937076.66976.71
32214379-221437973.83573.87
42264550-226455075.50875.52
51921434-192143464.06764.13
62054200-205420068.49468.53
15min12846473-284647394.91188.779.9695.0788.919.94
22793852-279385293.15793.31
32774858-277485892.52492.67
42867965-286796595.62895.75
52196666-219666673.24573.40
62493613-249361383.14683.28
20min13011274-3011274100.40695.666.85100.7095.946.84
22974452-297445299.17999.47
32960341-296034198.70899.00
43002915-3002915100.128100.40
52524316-252431684.17084.43
62740808-274080891.38891.65
30min13057669-3057669101.95399.901.92102.40100.321.93
23028443-3028443100.979101.42
33026541-3026541100.916101.35
43012971-3012971100.463100.88
52912860-291286097.12597.52
62937532-293753297.94898.35
45min13036322-3036322101.24299.921.03101.84100.491.05
23012382-3012382100.443101.03
33007417-3007417100.278100.87
43000498-3000498100.047100.62
52949683-294968398.35398.89
62973270-297327099.13999.69
60min13051818-3051818101.758100.431.05102.51101.161.07
23029359-3029359101.009101.75
33017505-3017505100.614101.35
43019806-3019806100.691101.41
52960029-296002998.69899.38
62994025-299402599.831100.53
极限13021491-3021491100.74799.651.08101.65100.521.09
23002991-3002991100.130101.02
32990644-299064499.719100.61
43014294-3014294100.507101.38
52937534-293753497.94898.78
62964706-296470698.85499.70
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